Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003888
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel Taxotere Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer
Detailed Description:
OBJECTIVES I Compare the progression free survival of patients with locally advanced inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy II Compare the response rate response duration toxicity local symptoms and time to disease progression of these treatment regimens in this patient population III Evaluate the quality of life in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to primary tumor site oral cavity vs oropharynx vs hypopharynx vs larynx and institution Patients are randomized to one of two treatment arms Arm I Patients receive docetaxel IV over 1 hour immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil 5-FU IV as a continuous infusion on days 1-5 Arm II Patients receive cisplatin IV over 1 hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course Radiotherapy is administered 5 days a week for up to 7 weeks Quality of life is assessed before treatment at courses 2 and 4 and at 6 and 9 months Patients are followed every 3 months for the first 2 years and then every 6 months until death
PROJECTED ACCRUAL A total of 348 patients will be accrued for this study within 24 months
OUTLINE This is a randomized multicenter study Patients are stratified according to primary tumor site oral cavity vs oropharynx vs hypopharynx vs larynx and institution Patients are randomized to one of two treatment arms Arm I Patients receive docetaxel IV over 1 hour immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil 5-FU IV as a continuous infusion on days 1-5 Arm II Patients receive cisplatin IV over 1 hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course Radiotherapy is administered 5 days a week for up to 7 weeks Quality of life is assessed before treatment at courses 2 and 4 and at 6 and 9 months Patients are followed every 3 months for the first 2 years and then every 6 months until death
PROJECTED ACCRUAL A total of 348 patients will be accrued for this study within 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RP-56976-V-323 | None | None | None |